Lilly's AWARD-11 trial studying higher investigational doses of Trulicity® (dulaglutide) demonstrated superiority in A1C reduction in people with type 2 diabetes

Wed June 26, 2019 6:45 AM|PR Newswire|About: LLY

INDIANAPOLIS, June 26, 2019 /PRNewswire/ -- Eli Lilly and Company's (NYSE: LLY) 

 https://www.lillydiabetes.com/ 

 FDA Approves Dupixent® (dupilumab) for Chronic Rhinosinusitis with Nasal Polyposis

Wed June 26, 2019 1:29 PM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, June 26, 2019 /PRNewswire/ --

 https://www.prnewswire.com/news-releases/fda-approves-dupixent-dupilumab-for-chronic-rhinosinusitis-with-nasal-polyposis-300875536.html 

 AbbVie Inc. (ABBV) CEO Rick Gonzalez on Acquisition of Allergan Conference Call (Transcript)

Jun. 25, 2019 3:28 PM ET|83 comments  | About: AbbVie Inc. (ABBV) 

 U.S. FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Heart Failure

Wed June 26, 2019 6:00 AM|PR Newswire|About: LLY

• - FDA's Fast Track designation for empagliflozin underscores the urgent need for new potential treatment options for the 6.5 million people in the U.S. who have heart failure

PR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, June 26, 2019 /PRNewswire/

 https://www.prnewswire.com/news-releases/us-fda-grants-fast-track-designation-to-empagliflozin-for-the-treatment-of-chronic-heart-failure-300874752.html 

 Amgen And MBC BioLabs Announce Winners Of The Amgen Golden Ticket

Tue June 25, 2019 4:00 PM|PR Newswire|About: AMGNPR Newswire

SAN FRANCISCO, June 25, 2019 /PRNewswire/ -- Amgen  (AMGN) and MBC BioLabs (formerly QB3@953) 

 https://www.prnewswire.com/news-releases/amgen-and-mbc-biolabs-announce-winners-of-the-amgen-golden-ticket-300874554.html 

  German Institute for Quality and Efficiency in Healthcare Publishes Rapid Report Noting Optune’s Survival Benefit for Patients with Newly Diagnosed Glioblastoma

Wed June 26, 2019 7:30 AM|Business Wire|About: NVCR

National reimbursement decision for Optune® in Germany anticipated in 2020

ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NVCR) 

 please visit www.novocure.com or follow us at www.twitter.com/novocure. 

 Bausch Health Announces U.S. Launch of DUOBRII™ (halobetasol propionate and tazarotene) Lotion 0.01%/0.045% for Plaque Psoriasis in Adults

Tue June 25, 2019 7:00 AM|Canada Newswire|About: BHC

LAVAL, Quebec, June 25, 2019 /CNW/ -- Bausch Health Companies Inc. (BHC) 

AbbVie to Acquire Allergan in Transformative Move for Both Companies

Tue June 25, 2019 6:42 AM|PR Newswire|About: ABBV, AGN

• THIS ANNOUNCEMENT IS BEING MADE PURSUANT TO RULE 2.5 OF THE IRISH TAKEOVER RULES

 PR Newswire

NORTH CHICAGO, Ill. and DUBLIN, June 25, 2019 /PRNewswire/ -- AbbVie Inc. (ABBV) and Allergan plc (AGN) 

Gilead and Carna Biosciences Announce Research and Development Collaboration to Develop Novel Immuno-Oncology Therapies

Mon June 24, 2019 7:00 PM|Business Wire|About: GILD

FOSTER CITY, Calif. & KOBE, Japan--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and Carna Biosciences Inc. (JASDAQ: 4572)

 https://www.carnabio.com/english/ 

Array BioPharma to Present Interim Analysis Results from Phase 3 BEACON CRC Trial of BRAFTOVI + MEKTOVI + Cetuximab for the Treatment of BRAFV600E- Mutant Metastatic Colorectal Cancer at the ESMO 21st World Congress on Gastrointestinal Cancer

Tue June 25, 2019 8:00 AM|PR Newswire|About: ARRY

BOULDER, Colo., June 25, 2019 /PRNewswire/ -- Array BioPharma Inc. (ARRY) 

 AbbVie Receives Positive Recommendation from the Institut national d'excellence en santé et en services sociaux (INESSS) for the Combination VENCLEXTA® With Rituximab as a Treatment for Patients With Chronic Lymphocytic Leukemia

Tue June 25, 2019 9:00 AM|Canada Newswire|About: ABBV 

• INESSS recommends the reimbursement of VENCLEXTA® (venetoclax) in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia (CLL).i
• Adult patients with CLL taking VENCLEXTA in combination with rituximab can stop their therapy after a defined treatment period of 24 months on treatment.

MONTREAL, June 25, 2019 /CNW/ - AbbVie (ABBV)

 https://www.rituxan.com/ 

Amarin Corporation plc. (AMRN) CEO John Thero Presents at 2019 BMO Prescription For Success Healthcare Conference (Transcript)

Jun. 25, 2019 3:27 PM ET  | About: Amarin Corporation plc (AMRN) 

 https://amarincorp.com/ 

  June 24, 2019

Minerva Neurosciences Announces Achievement of Primary and Key Secondary Objectives in Phase 2b Clinical Trial of Seltorexant (MIN-202) in Insomnia

 Minerva Neurosciences,... (NERV) 

 William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376 

Bristol-Myers Squibb Announces Results from CheckMate -459 Study Evaluating Opdivo (nivolumab) as a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

Mon June 24, 2019 6:59 AM|Business Wire|About: BMY

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) 

FDA Grants Face-to-Face Meeting to Discuss CytoDyn’s 510(k) Application for ProstaGene™ Prognostic Test

Mon June 24, 2019 6:00 AM|GlobeNewswire|About: CYDY

VANCOUVER, Washington, June 24, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY),

 https://www.cytodyn.com/media/press-releases/detail/341/fda-grants-face-to-face-meeting-to-discuss-cytodyns 

Mallinckrodt Achieves 50 Percent Enrollment for Phase 2B Trial Investigating the Use of Acthar® Gel (Repository Corticotropin Injection) in Amyotrophic Lateral Sclerosis (ALS)

Mon June 24, 2019 6:55 AM|PR Newswire|About: MNK

STAINES-UPON-THAMES, United Kingdom, June 24, 2019 /PRNewswire/ -- Mallinckrodt plc (MNK) (NYSE: MNK)

Allergan Receives FDA Clearance For CoolTone™ Device

Mon June 24, 2019 7:30 AM|PR Newswire|About: AGNPR Newswire

DUBLIN, June 24, 2019 /PRNewswire/ -- Allergan plc (AGN)

 https://www.prnewswire.com/news-releases/allergan-receives-fda-clearance-for-cooltone-device-300873208.html 

 https://www.allergan.com/news/news/thomson-reuters/allergan-receives-fda-clearance-for-cooltone-devic 

 AbbVie Announces US FDA Lifts Partial Clinical Hold on Phase 3 Study of Venetoclax in Patients with Multiple Myeloma Positive for the t(11;14) Genetic Abnormality

• Mon June 24, 2019 8:45 AM|PR Newswire|About: ABBV
• - The t(11;14) genetic biomarker is among the most common and routinely tested genetic abnormalities in patients with multiple myeloma[1]

PR Newswire

NORTH CHICAGO, Ill., June 24, 2019 /PRNewswire/ -- AbbVie (ABBV) 

 VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers.  

 https://www.prnewswire.com/news-releases/abbvie-announces-us-fda-lifts-partial-clinical-hold-on-phase-3-study-of-venetoclax-in-patients-with-multiple-myeloma-positive-for-the-t1114-genetic-abnormality-300873381.html 

FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity

Fri June 21, 2019 7:30 AM|PR Newswire|About: AGN

• --Approval Marks 10th BOTOX® Therapeutic Indication in its 30th Anniversary Year--

PR Newswire

DUBLIN, June 21, 2019 /PRNewswire/ -- Allergan plc (AGN)

 https://www.prnewswire.com/news-releases/fda-approves-botox-onabotulinumtoxina-for-pediatric-patients-with-upper-limb-spasticity-300872470.html 

European Commission Approves TALZENNA® (talazoparib) for Patients with Inherited (Germline) BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

Fri June 21, 2019 10:45 AM|Business Wire|About: PFE

Only once-daily PARP inhibitor approved in Europe for hereditary breast cancer

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE

 https://www.businesswire.com/news/home/20190621005322/en/ 

 Illumina Introduces Expanded Version of VeriSeq™ NIPT Solution, Offering More Comprehensive Detection of Rare Chromosomal Conditions

Next-generation Sequencing-based Solution Provides Accurate, Fast and Scalable End-to-end Genome-wide Noninvasive Prenatal Testing

SAN DIEGO--(BUSINESS WIRE)--Jun. 4, 2019-- Illumina, Inc. (NASDAQ: ILMN

 FDA Approves SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene

Fri June 21, 2019 2:30 PM|Business Wire|About: VRTX

-SYMDEKO is now approved for patients 6 years of age and older with two copies of the F508del mutation or one copy of a responsive mutation-

-Vertex (VRTX)'s third medicine approved to treat the underlying cause of CF in eligible patients in this age range-

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)

 https://www.businesswire.com/news/home/20190621005443/en/ 

 BD Statement on FDA Circulatory System Devices Panel Regarding Paclitaxel-Coated Devices

Thu June 20, 2019 5:45 PM|PR Newswire|About: BDX

FRANKLIN LAKES, N.J., June 20, 2019 /PRNewswire/ -- BD (Becton, Dickinson and Company (BDX)) (NYSE: BDX)

 https://www.prnewswire.com/news-releases/bd-statement-on-fda-circulatory-system-devices-panel-regarding-paclitaxel-coated-devices-300872436.html 

 Amarin’s John Thero Awarded NJ EY Entrepreneur of The Year® 2019 Award for Life Sciences

Fri June 21, 2019 1:39 PM|GlobeNewswire|About: AMRN

BEDMINSTER, N.J. and DUBLIN, Ireland, June 21, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation (AMRN) plc (NASDAQ:AMRN)

 https://amarincorp.com/products.html 

U.S. FDA Accepts Supplemental Biologics License Application (sBLA) for ULTOMIRIS® (ravulizumab-cwvz) under Priority Review for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS)

Thu June 20, 2019 8:15 AM|Business Wire|About: ALXN

- FDA sets target action date of October 19, 2019 -

BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (ALXN) 

BeiGene Announces Phase 1b Clinical Results of Zanubrutinib in Combination with GAZYVA® (Obinutuzumab) in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Follicular Lymphoma at the 15th International Conference on Malignant Lymphoma (ICML)

Thu June 20, 2019 11:05 AM|GlobeNewswire|About: BGNE

CAMBRIDGE, Mass. and BEIJING, China, June 20, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

 https://www.gazyva.com/ 

 Regeneron and Sanofi Announce Positive Topline Phase 2 Results for IL-33 Antibody in Asthma

Fri June 21, 2019 12:59 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, June 21, 2019 /PRNewswire/ -- 

REGN3500 monotherapy significantly reduced loss of asthma control and improved lung function compared to placebo

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi

 Janssen Announces Collaboration with University of California, Berkeley and University of California, San Francisco to Expand Data Science Research in Healthcare

Thu June 20, 2019 9:00 AM|Business Wire|About: JNJ

The program facilitated by Johnson & Johnson Innovation will recruit data scientists to research high impact, data-science projects in healthcare

SAN FRANCISCO--(BUSINESS WIRE)-- Janssen Research & Development, LLC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ)   

 https://www.businesswire.com/news/home/20190620005351/en/ 

QIAGEN Clinical Insight Surpasses 1 Million Patient Test Cases Analyzed and Interpreted

Thu June 20, 2019 10:00 AM|Business Wire|About: QGEN

Industry-leading bioinformatics software delivers genomic insights for precision medicine

HILDEN, Germany & GERMANTOWN, Md.--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA)

 https://www.businesswire.com/news/home/20190620005371/en/ 

Editas Medicine (EDIT) Investor Presentation - Slideshow

Jun. 20, 2019 12:07 PM ET|2 comments | About: Editas Medicine, Inc. (EDIT) 

 Arena Pharmaceuticals Announces First Subject Dosed in ELEVATE UC 52 Global Phase 3 Trial Evaluating Etrasimod in Ulcerative Colitis

Mon June 17, 2019 8:30 AM|PR Newswire|About: ARNA

• - ELEVATE UC clinical trial sites continue to initiate

PR Newswire

SAN DIEGO, June 17, 2019 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (ARNA) (Nasdaq: ARNA)

 Ironwood and Allergan Report Positive Topline Data from Phase IIIb Trial of LINZESS® (linaclotide) in Adults with Irritable Bowel Syndrome with Constipation (IBS-C)

Tue June 18, 2019 4:05 PM|Business Wire|About: AGN, IRWD 

FDA Approves Amgen And Allergan's KANJINTI™ (trastuzumab-anns), A Biosimilar To Herceptin® (trastuzumab)

• Thu June 13, 2019 7:13 PM|PR Newswire|About: AGN, AMGN
• Third FDA Approval From Amgen's Biosimilars Portfolio

PR Newswire

THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ -- Amgen (AMGN) and Allergan plc (AGN)

 BeiGene and SpringWorks Therapeutics Announce the Formation of MapKure to Develop BGB-3245, an Investigational, Selective Next-Generation RAF Kinase Inhibitor

Tue June 18, 2019 7:00 AM|GlobeNewswire|About: BGNE

CAMBRIDGE, Mass. and BEIJING, China and STAMFORD, Conn., June 18, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

 Gilead and Nurix Establish Strategic Collaboration to Develop Novel Therapies for Cancer and Other Diseases

Wed June 19, 2019 8:30 AM|GlobeNewswire|About: GILDGlobeNewswire

FOSTER CITY, Calif. and SAN FRANCISCO, June 19, 2019 (GLOBE NEWSWIRE) -- Gilead Sciences, Inc. (GILD) and Nurix Therapeutics, Inc

 Amgen And The Institute For Protein Design (IPD) At University Of Washington Announce Unique Strategic Research Partnership

Wed June 19, 2019 4:00 PM|PR Newswire|About: AMGNPR Newswire

THOUSAND OAKS, Calif. and SEATTLE, June 19, 2019 /PRNewswire/ -- Amgen (AMGN) and the University of Washington's Institute for Protein Design (IPD)

 https://www.prnewswire.com/news-releases/amgen-and-the-institute-for-protein-design-ipd-at-university-of-washington-announce-unique-strategic-research-partnership-300871544.html 

Sorrento Therapeutics Updates Positive Results of Phase 1b Resiniferatoxin (RTX) in Knee Osteoarthritis Pain Trial

Wed June 19, 2019 7:00 AM|GlobeNewswire|About: SRNE 

 Regeneron CD20xCD3 Bispecific REGN1979 Shows Positive Results in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma, including in CAR-T Failures

Fri June 14, 2019 7:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., June 14, 2019 /PRNewswire/ 

 MorphoSys's Licensee Janssen Announces Top-line Phase 3 Results for Guselkumab (Tremfya(R)) in Adults with Active Psoriatic Arthritis

Fri June 14, 2019 8:20 AM|Accesswire|About: JNJ, MOR, MPSYY

PLANEGG and MUNICH, GERMANY / ACCESSWIRE / June 14, 2019 / MorphoSys AG (MPSYF) (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) 

 Bausch + Lomb ULTRA® Multifocal for Astigmatism Contact Lenses Now Available In the United States

Wed June 19, 2019 7:00 AM|PR Newswire|About: BHC

New Lens is the Most Advanced Soft Contact Lens Design in Bausch + Lomb History

Only Multifocal Toric Lens that Offers Eye Care Professionals a Convenient Same-Day Fit to Address Patients with Astigmatism and Presbyopia

BRIDGEWATER, N.J., June 19, 2019 /PRNewswire/ -- Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies Inc. (BHC)

 AstraZeneca and Merck’s LYNPARZA® (olaparib) Approved in Japan as First-Line Maintenance Therapy in Patients with BRCA-Mutated Advanced Ovarian Cancer

Wed June 19, 2019 6:45 AM|Business Wire|About: MRK

LYNPARZA is the Only PARP Inhibitor Approved in Japan

KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK)

Lilly Presents Positive Results for Taltz® (ixekizumab) vs. Humira® (adalimumab) in a Head-to-Head (SPIRIT-H2H) Superiority Study in Patients with Active Psoriatic Arthritis at the European Congress of Rheumatology

Fri June 14, 2019 3:24 PM|Canada Newswire|About: LLY

TORONTO, June 14, 2019 /CNW/ - Eli Lilly and Company (LLY)

LYNPARZA® (olaparib) Approved in the EU for Use as First-Line Maintenance Therapy in Patients With BRCA-Mutated Advanced Ovarian Cancer

Tue June 18, 2019 6:30 AM|Business Wire|About: MRK

AstraZeneca and Merck’s LYNPARZA Reduced the Risk of Disease Progression or Death by 70% Compared to Placebo Following Response to Platinum-Based Chemotherapy in Phase 3 SOLO-1 Trial

LYNPARZA is the Only PARP Inhibitor Approved in the EU for This Indication

KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK), 

BioMarin Announces New England Journal of Medicine Publishes Vosoritide Phase 2 Study Showing Sustained Annualized Growth Up to 42 Months in Children with Achondroplasia

Tue June 18, 2019 8:31 AM|PR Newswire|About: BMRNPR Newswire

SAN RAFAEL, Calif., June 18, 2019 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

FDA approves Novo Nordisk's Type 2 diabetes drug for young patients

Jun. 17, 2019 6:03 PM ET|About: Novo Nordisk A/S (NVO)|By: Carl Surran, SA News Editor 

BeiGene Announces Updated Results from a Pivotal Phase 2 Study of Tislelizumab in Chinese Patients with Relapsed or Refractory Classical Hodgkin Lymphoma at the 24th Congress of the European Hematology Association (EHA)

Fri June 14, 2019 2:30 AM|GlobeNewswire|About: BGNEGlobeNewswire

CAMBRIDGE, Mass. and BEIJING, China, June 14, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

bluebird bio Presents Long-Term Efficacy and Safety Data from Clinical Studies of LentiGlobin® Gene Therapy for Transfusion-Dependent β-Thalassemia (TDT) at 24th European Hematology Association (EHA) Congress

Fri June 14, 2019 5:31 AM|Business Wire|About: BLUE 

Pfizer to Acquire Array BioPharma

Mon June 17, 2019 6:54 AM|PR Newswire|About: ARRY, PFE 

 PR Newswire

NEW YORK, and BOULDER, Colo., June 17, 2019 /PRNewswire/ -- Pfizer Inc (PFE) and Array BioPharma Inc. (ARRY) 

AstraZeneca's Lokelma helped improve potassium levels in dialysis patients

Jun. 14, 2019 8:09 AM ET|About: AstraZeneca PLC (AZN)|By: Liz Kiesche, SA News Edito 

 New Mechanistic Study Explores the Relationship Between a Key Genetic Marker and Clinical Efficacy of ORENCIA® (abatacept) or adalimumab in Moderate-to-Severe Early Rheumatoid Arthritis Patients

Thu June 13, 2019 4:30 PM|Business Wire|About: BMY 

CALQUENCE® (acalabrutinib) Significantly Prolonged the Time Patients Lived without Disease Progression in Relapsed or Refractory  

Chronic Lymphocytic Leukemia

Sat June 15, 2019 7:00 AM|Business Wire|About: AZN

An encouraging 88% of patients on CALQUENCE remained free of disease progression after 12 months, vs. 68% of patients on rituximab combined with idelalisib or bendamustine

WILMINGTON, Del.--(BUSINESS WIRE)--

Amgen Announces BLINCYTO® (blinatumomab) Five-Year Overall Survival Data At EHA 2019

• Sun June 16, 2019 2:00 AM|PR Newswire|About: AMGN
• More Than Half of Patients who Achieved an MRD-Negative Complete Response Still Alive at Five Years
• Only CD19-Targeted Immuno-oncology Therapy With Five-Year Survival Data

PR Newswire

THOUSAND OAKS, Calif., June 15, 2019 /PRNewswire/ -- Amgen (AMGN) 

 ULTOMIRIS® (ravulizumab) Receives Marketing Authorization from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the Treatment of Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Tue June 18, 2019 6:30 AM|Business Wire|About: ALXN 

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Monotherapy for Patients with Metastatic Small Cell Lung Cancer (SCLC) with Disease Progression on or After Platinum-Based Chemotherapy and at Least One Other Prior Line of Therapy

Tue June 18, 2019 6:45 AM|Business Wire|About: MRK

Marks First Approval for KEYTRUDA in SCLC

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)

 Neurocrine Biosciences to Present Data on INGREZZA® (valbenazine) and Opicapone at the 2019 World Congress on Parkinson's Disease and Related Disorders

Tue June 11, 2019 4:01 PM|PR Newswire|About: NBIX

- Pooled Analyses of Two Pivotal Studies Showed Opicapone Reduced OFF Time and Was Generally Well Tolerated in More than 500 Patients with Parkinson's Disease and Motor Fluctuations

PR Newswire

SAN DIEGO, June 11, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX)

 https://www.prnewswire.com/news-releases/neurocrine-biosciences-to-present-data-on-ingrezza-valbenazine-and-opicapone-at-the-2019-world-congress-on-parkinsons-disease-and-related-disorders-300865804.html 

FDA Grants Priority Review to Genentech’s Rituxan (Rituximab) in Children with Two Rare Blood Vessel Disorders

Wed June 12, 2019 1:00 AM|Business Wire|About: RHHBY

• There are currently no FDA approved treatments for children living with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
• The PePRS study is the first global trial of Rituxan in pediatric patients with GPA or MPA
• Rituxan in combination with glucocorticoids is the only FDA-approved therapy for adults with these two rare forms of vasculitis
• If approved, this would be the first pediatric indication for Rituxan

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

BeiGene Announces Clinical Data on Zanubrutinib to Be Presented at the 15th International Conference on Malignant Lymphoma (ICML)

Wed June 12, 2019 4:00 AM|GlobeNewswire|About: BGNEGlobeNewswire

CAMBRIDGE, Mass. and BEIJING, China, June 12, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

Varian Medical Systems Presents Latest Innovations in Radiotherapy at DEGRO 25

Wed June 12, 2019 4:00 AM|PR Newswire|About: VAR

MÜNSTER, Germany, June 12, 2019 /PRNewswire/ -- Varian (VSEA) (NYSE: VAR)

Alkermes Advances ALKS 4230 into Monotherapy Expansion Phase of ARTISTRY-1 in Patients With Renal Cell Carcinoma or Melanoma

Wed June 12, 2019 7:00 AM|PR Newswire|About: ALKS 

 PR Newswire

DUBLIN, June 12, 2019 /PRNewswire/ -- Alkermes plc (ALKS) (Nasdaq: ALKS) 

 https://www.prnewswire.com/news-releases/alkermes-advances-alks-4230-into-monotherapy-expansion-phase-of-artistry-1-in-patients-with-renal-cell-carcinoma-or-melanoma-300866051.html 

 http://www.alkermes.com/ 

 Oral semaglutide demonstrated cardiovascular safety in people with type 2 diabetes and established cardiovascular disease or high cardiovascular risk in PIONEER 6 trial

SAN FRANCISCO, June 11, 2019 /PRNewswire/

 Array BioPharma (ARRY) Investor Presentation - Slideshow

Jun. 11, 2019 3:49 PM ET | About: Array BioPharma Inc. (ARRY) 

 June 11, 2019

New Two-Year Data at the 24th World Congress of Dermatology Shows SKYRIZI™ (risankizumab) Maintains Complete Skin Clearance

 NORTH CHICAGO, Ill., June 11, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), 

 INVOKANA® (canagliflozin) Significantly Reduced Major Cardiovascular Events and Kidney Failure in Patients with Type 2 Diabetes and Chronic Kidney Disease in New CREDENCE Analysis 

 SAN FRANCISCO, June 11, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson 

Agilent Companion Diagnostic Gains Expanded FDA Approval in Head and Neck Squamous Cell Carcinoma (HNSCC)

Tue June 11, 2019 7:56 AM|Business Wire|About: A

PD-L1 IHC 22C3 pharmDx can now be used as an aid to identify HNSCC patients for treatment with KEYTRUDA® (pembrolizumab)

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (A) 

 https://www.businesswire.com/news/home/20190611005542/en/ 

Varian to Demonstrate New Bravos Afterloader System at ABS 2019

Tue June 11, 2019 8:15 AM|PR Newswire|About: VAR

PALO ALTO, Calif., June 11, 2019 /PRNewswire/ -- Varian (VSEA) (NYSE: VAR

 IMBRUVICA® (ibrutinib) Long-Term Data from Two Pivotal Phase 3 Studies at ASCO and EHA Demonstrate Sustained Efficacy and Safety in Patients with Chronic Lymphocytic Leukemia (CLL) 

 CHICAGO and AMSTERDAM, June 3, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson  

AbbVie's MAVIRET™ now listed on the Nova Scotia and Manitoba formularies

Mon June 10, 2019 8:00 AM|Canada Newswire|About: ABBV

• MAVIRET is the first and only 8-week, pan-genotypic treatment for patients with chronic hepatitis C virus (HCV) infection without cirrhosis and who are new to treatment.*1
• MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease (CKD).

MONTREAL, June 10, 2019 /CNW/ - AbbVie (ABBV)

 http://www.abbvie.ca/ 

 Positive Feline Clinical Trial Outcome Motivates Sorrento Therapeutics to Accelerate Human IND Filing of Resiniferatoxin (RTX) for Prolonged Non-Opioid Control of Post-Amputation Neuropathic Pain

Mon June 10, 2019 7:00 AM|GlobeNewswire|About: SRNE

SAN DIEGO, June 10, 2019 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (SRNE)

FDA Approves Two New Indications for Merck’s KEYTRUDA® (pembrolizumab)

Tue June 11, 2019 6:45 AM|Business Wire|About: MRK

KEYTRUDA Now Approved for First-Line Treatment of Patients with Metastatic or with Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma as Monotherapy for Patients Whose Tumors Express PD-L1 (CPS ≥1) or in Combination with Platinum and Fluorouracil (FU) Regardless of PD-L1 Expression

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)

 https://www.businesswire.com/news/home/20190611005275/en/ 

FDA Grants Genentech’s Polivy Accelerated Approval for People with Previously Treated Aggressive Lymphoma

Mon June 10, 2019 12:36 PM|Business Wire|About: RHHBY

– New targeted medicine shown to improve clinical outcomes in people with relapsed or refractory diffuse large B-cell lymphoma compared to a commonly used regimen –

– First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells –

– Ninth indication with Breakthrough Therapy Designation in Genentech’s hematology portfolio to receive FDA approval –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

 https://www.businesswire.com/news/home/20190610005588/en/ 

Tetraphase Pharmaceuticals Announces New XERAVA™ (eravacycline) Data at the 39th Annual Surgical Infection Society Meeting

Mon June 10, 2019 7:00 AM|Business Wire|About: TTPH

-Study Examines Microbiology and Hospitalization Outcomes Among Complicated Intra-Abdominal Infection Patients-

-Data Underscore XERAVA’s Role as an Empiric Treatment Option for Patients With Complicated Intra-Abdominal Infections-

WATERTOWN, Mass.--(BUSINESS WIRE)-- Tetraphase Pharmaceuticals, Inc. (TTPH) (NASDAQ:TTPH)

 https://www.businesswire.com/news/home/20190610005030/en/ 

 Sesen Bio Announces Successful Pre-BLA Meeting with FDA for Vicinium®

Mon June 10, 2019 7:00 AM|Business Wire|About: SESN

FDA Recommends Accelerated Approval Pathway

FDA Indicated No Additional Clinical Trials Necessary for BLA Submission

Company Expects to Initiate Submission of the BLA in 4Q 2019 Under Rolling Review

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sesen Bio (SESN) (Nasdaq:SESN)

 https://www.businesswire.com/news/home/20190610005190/en/ 

 Veracyte Announces New Publication of Data Demonstrating Real-World Performance of the Afirma GSC in Thyroid Cancer Diagnosis

Mon June 10, 2019 4:15 PM|Business Wire|About: VCYT

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc (VCYT)

 http://www.afirma.com/patients/ 

Detailed findings from CAROLINA® outcome trial support long-term cardiovascular safety profile of Tradjenta®

Mon June 10, 2019 9:30 PM|PR Newswire|About: LL 

• Adults with diabetes treated with Tradjenta experienced fewer events of hypoglycemia and a modest weight reduction compared with glimepiride
• - Detailed results from CAROLINA were presented at the American Diabetes Association's 79th Scientific Sessions

PR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, June 10, 2019 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (LLY) 

 https://www.tradjenta.com/ 

 https://www.prnewswire.com/news-releases/detailed-findings-from-carolina-outcome-trial-support-long-term-cardiovascular-safety-profile-of-tradjenta-300864614.html 

Lilly to Present 5-Year Sustained Efficacy and Safety Results for Taltz® (ixekizumab) in Patients with Plaque Psoriasis at the World Congress of Dermatology

Tue June 11, 2019 3:00 AM|PR Newswire|About: LLY

INDIANAPOLIS, June 11, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY) 

 https://www.taltz.com/ 

Genentech’s Gazyva (Obinutuzumab) Delivers Positive Topline Results for Phase II Lupus Nephritis Study

Tue June 11, 2019 1:00 AM|Business Wire|About: RHHBY

• NOBILITY showed that Gazyva helped more patients achieve a complete renal response when added to standard of care
• The Phase II study met both primary and key secondary endpoints
• There are currently no FDA-approved therapies for lupus nephritis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

 https://www.businesswire.com/news/home/20190610005836/en/ 

New analysis shows cardiorenal risk reductions of Jardiance® are consistent in adults with type 2 diabetes, cardiovascular disease and kidney disease without overt proteinuria

Mon June 10, 2019 1:00 PM|PR Newswire|About: LLYPR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, June 10, 2019 /PRNewswire/

 https://www.prnewswire.com/news-releases/new-analysis-shows-cardiorenal-risk-reductions-of-jardiance-are-consistent-in-adults-with-type-2-diabetes-cardiovascular-disease-and-kidney-disease-without-overt-proteinuria-300864270.html 

FARXIGA Study Showed Reduced Progression of Kidney Disease or Renal Death in Patients with Type 2 Diabetes

Mon June 10, 2019 8:00 AM|Business Wire|About: AZN

FARXIGA showed a 47% reduction in the composite of kidney function decline, end-stage renal disease or renal death in a pre-specified analysis from DECLARE-TIMI 58

WILMINGTON, Del.--(BUSINESS WIRE)

 https://www.businesswire.com/news/home/20190610005198/en/ 

 Jun. 8, 2019 5:21 PM ET|About: Amgen Inc. (AMGN), AZN, BMY, CELG, LLY, MRK, PFE

Summary

politicos started the BIOTECH-WARS™ and they are continuing the war.

the BIOTECH-WAR$ led to the vilification of the biotech sector.

the Biotech industry severely miscalculated and underestimated the situation they find themselves in.

 Jun. 5, 2019 4:18 PM ET|About: AbbVie Inc. (ABBV), AMGN, BMRN, CELG, JNJ, LLY, MRK, NVS, PFE, RHHBY

Summary

The perfect BIOTECH$TORM is not over, perhaps it is only in the early stages.

In NJ more taxes coming, more pain, more debt, unfunded liabilities, and in my view a rapid exit of many high-income people from my home state of New Jersey.

Nevertheless, meanwhile and more importantly Biotech Companies continue to make significant product and financial progress irrespective of the negative political environment that only seems to be getting worse.

 Jun. 3, 2019 12:30 PM ET|About: Amgen Inc. (AMGN), AZN, BMY, CELG, GILD, MRK, NVS, RHHBY, SGEN

Summary

The Perfect BIOTECH$TORM is occurring right now, June 2019.

Trade Wars, Legal Battles, Political Battles, all impact to create the Perfect BIOTECHSTORM.

Nevertheless Biotech companies continue to develop wonderful new products every day.

 May 24, 2019 11:56 AM ET|About: Celgene Corporation (CELG), JNJ, LLY, MRK, NVS, Includes: ABBV, ARRY, MDT, PFE

Summary

the BIOTECH WAR$ have expanded to include a new and unexpected target, “wealthy people”.

the victorious party wants to remove all undesirable citizens/unlikely supporters from the state in which they live. Acrimony against biotech companies and now wealthy citizens is where we are at.

Biotech companies are an insufficient sector to the politico’s, and a more expansive “Bad Guy Group” is now needed – i.e., wealthy people, especially if you live in NJ

 May 9, 2019 8:52 AM ET|About: Johnson & Johnson (JNJ), MRK

Summary

the BIOTECH WAR$ may represent a deeper battle going on between the “Socialist” political movement and our current “Capitalistic” economy.

Achieving political power supersedes common sense and support for the biotech business sector becomes non-existent as the sector is politically vilified.

Positive biotech product news seems to have little effect towards improving market valuations.

 Apr. 30, 2019 5:44 PM ET|About: Amgen Inc. (AMGN), JNJ, MRK, Includes: BMY, CELG, NVO, NVS, PFE, RHHBY

Summary

The “Medicare for all” and the “drug pricing” messaging is working for all those who seek political gain.

Biotech, Medtech and the entire Healthcare sector are losing the battles, and the war as investors flee for less politically targeted sectors.

NJ residents see the "P/C", "Middle Class Only"/ Socialism wave coming.

I may need to stop being so publicly supportive of Biotech companies.

 Feb. 20, 2019 11:04 PM ET|Includes: AbbVie Inc. (ABBV), ABT, ALKS, AMGN, CELG, CERC, CLVS, JNJ, LLY, MDT, MRK, NVO, PFE

Summary

A BIOTECH VORTEX™ is occurring across the entire healthcare sector as companies are now Seeking Biotech Partnerships to gain momentum.

Biotech & Biotech Partnerships.

Biotech & Medtech Partnerships.

Biotech & Medtech & Medical Universities Partnerships.

Biotech & Health Systems Partnerships.

  Mar. 6, 2019 8:12 AM ET|Includes: AbbVie Inc. (ABBV), AMGN, AZN, BMY, CELG, JNJ, LLY, MRK, PFE, SRPT

Summary

Sometimes biotech news is wonderful news.

Sometimes biotech news is the best and most upbeat news I read all day.

Sometimes with great effort and much time and money spent biotech news is remarkable news for many people seeking solutions to specific medical conditions and aliments.

The first 2 months of 2019 have been extremely strong for many of my biotech positions.

 Feb. 1, 2019 9:27 PM ET|

6 comments |Includes: Abiomed, Inc. (ABMD), BIIB, ILMN, ISRG, MRK, RHHBY, SRPT, VA 

 Almost every piece of company news I was reading was positive and encouraging during the December 2018 time frame. 

 Feb. 12, 2019 4:16 PM ET|2 comments |About: AbbVie Inc. (ABBV), AZN, BMY, JNJ, MRK, PFE, SNY

Summary

Biotech companies are easy targets as they are on TV with their advertised products on a year-round basis and they are successful and profitable.

If an incumbent senator can successfully attack a successful and profitable biotech company, that is in his home state, then so can everyone else.

Should any politician target any biotech company in their home state, then most likely they will win votes and are more likely to win elections.

I think these hearings will eventually benefit biotech companies as insurance companies and PBM's and other "profiteers" in the healthcare pricing matrix are exposed.

As a biotech investor the upcoming/ongoing congressional hearings on drug pricing (2/26/2019) does have me feeling a bit on edge.   

  Apr. 2, 2019 8:20 PM ET|About: AstraZeneca PLC (AZN), BMY, CELG, Includes: AMRN, JNJ, MRK, NVO, NVS, PFE, RHHBY, SNY

Summary

“TINSTAAFL” = “There is no such thing as a free lunch”.

Princeton NJ/Central Jersey – is for me the best example of a successful BioTECH Zone.

Ireland's Life Sciences sector has grown from very humble beginnings in the 1960s to reach global significance. Collaborative clusters in Pharmaceutical, Biotechnology, Medical Devices and Diagnostics have been a key.

AstraZeneca is spearheading the creation of a new life sciences park, in Wuxi, China, that aims to nurture innovation.

Cambridge, Mass, is one of the best examples of a successful BioTECH Zone.

 Mar. 14, 2018 1:14 PM ET|About: Amgen Inc. (AMGN), AZN, BGNE, CELG, NVS, Includes: ABMD, BMY, LLY, MDT, MRK, NVO

Summary

China Bio-Tech growth is accelerating now.

China needs better healthcare in every province.

China will welcome all bio-technology partnerships.

China is on the verge of major investment changes.